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Opioid DEA Substance Abuse

Goodwin

SAMHSA Final Rule Codifies Opioid Treatment Program Telehealth and Take-Home Medication Flexibilities

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On February 2, 2024, the Department of Health and Human Services (HHS) issued a Final Rule that expands access to medications for the treatment of opioid use disorder (OUD) via telehealth modalities and “take-home” doses....more

Console and Associates, P.C.

Parents Bring Kratom Lawsuits Following Overdose Deaths and Other Serious Injuries

Kratom, a natural substance derived from the leaves of the Mitragyna speciosa tree, has recently gained notoriety for its potential dangers. While proponents cite its therapeutic benefits, concerns have surged about its...more

Foley & Lardner LLP

2023 Telemedicine & Digital Health Trends

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Medicare telehealth post-Public Health Emergency (PHE): With the COVID-19 PHE concluding on May 11, 2023, many of the telehealth flexibilities the Centers for Medicare & Medicaid Services (CMS) implemented during the PHE will...more

Quarles & Brady LLP

DEA’s “X” Waiver Eliminated by Congress

Quarles & Brady LLP on

On December 29, 2022, the Consolidated Appropriations Act of 2023 (Public Law No. 117-328) (the “Legislation”) was signed into law, which, under Section 1262 of the Legislation, contains the Mainstreaming Addiction Treatment...more

Foley & Lardner LLP

DEA Chopping Block: DATA-Waiver Requirement

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On January 12, 2023, the Drug Enforcement Administration (DEA) confirmed in a letter to registrants that the Consolidated Appropriations Act of 2023 (P.L. 117-328) (the Act), which was signed into law on December 29, 2022,...more

Foley & Lardner LLP

Expanded Medicare Telehealth Coverage for Opioid Use Disorder Treatment Services Furnished by Opioid Treatment Programs

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Starting January 1, 2023, Medicare will cover telehealth-based treatment services delivered by federally-accredited opioid treatment programs (OTPs), commonly referred to as “methadone clinics.” This new reimbursement is...more

Mintz - Health Care Viewpoints

FDA Announces Review of Opioid Prescribing Regulations and Framework for Preventing Overdose-Related Deaths

The head of the Food and Drug Administration (FDA), Dr. Robert Califf, announced on August 30, 2022 that, in addition to an extensive review of opioid regulations, the agency is launching a framework aimed at preventing...more

The Volkov Law Group

DOJ Files Civil Complaint Against Walmart for Illegal Opioid Distribution

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The Justice Department handed Walmart a huge slap in the face last year with the filing of a comprehensive civil case alleging that Walmart knowingly distributed large quantities of opioids in disregard of the law that fueled...more

Mintz - Health Care Viewpoints

DEA Releases Long-Awaited Suspicious Orders Proposed Rule

It has been a long time coming. On November 2, 2020, the Drug Enforcement Administration (DEA) released its long-awaited proposed rule to revise the regulations related to suspicious orders of controlled substances. The...more

Oberheiden P.C.

DEA Compliance for 2021 - How the DEA’s 2021 Proposed Aggregate Production Quotas Affect Pharmaceutical Companies and Society

Oberheiden P.C. on

The DEA struggles to balance the pressing need to provide pain relief for those suffering from the novel coronavirus with the ongoing effort to reduce the opioid epidemic in the United States. I. Overview on the DEA and the...more

ArentFox Schiff

Investigations Newsletter: Department of Justice Announces $8.3 Billion Settlement with Opioid Manufacturer Purdue Pharma and...

ArentFox Schiff on

Department of Justice Announces $8.3 Billion Settlement with Opioid Manufacturer Purdue Pharma and Members of the Sackler Family - On October 21, the Department of Justice (DOJ) announced that it reached a global resolution...more

Foley & Lardner LLP

Telehealth and Substance Use Disorder Treatment: Regulatory Barriers to Entry Can Mean Opportunity for Innovative Companies

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...As COVID-19 cases spread across the U.S., another public health issue continues to escalate: the rise of opioid-related overdose deaths. For patients with a substance use disorder (SUD), the pandemic has increased feelings...more

Harris Beach PLLC

Why We Support Take Back Day

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The Drug Enforcement Agency’s National Prescription Drug Take Back Day is tomorrow: Saturday, October 26. This day has evolved over the years to address the growing opioid crisis, including misuse and abuse of unused...more

Troutman Pepper

Protecting Your Company From Increased Scrutiny After Release of ARCOS Opioid Data

Troutman Pepper on

In July, The Washington Post published data showing approximately 76 billion oxycodone and hydrocodone pills were purchased and sold in the Unites States from 2006 to 2012. The data came from the Automation of Reports and...more

Patrick Malone & Associates P.C. | DC Injury...

Another front in war on opioids: Criminal charges for Big Pharma execs, MDs

An estimated 400,000 Americans have died due to opioid drug overdoses between 1999 and 2017 — and the fatalities only are increasing. By 2025, according to expert forecasts, there will be 700,000 more opioid deaths....more

Foley & Lardner LLP

Pharmacies: DOJ Wins TRO to Immediately Suspend Registration for Controlled Substances

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In February, the Department of Justice (DOJ) successfully leveraged a new weapon to target pharmacies as it battles the nation’s opioid crisis. The new approach utilizes court-ordered temporary restraining orders (TROs) that...more

King & Spalding

Court Grants TRO Requested by DOJ to Shut Down Pharmacies Accused of Controlled Substances Act Violations

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On Thursday, February 7, 2019, the U.S. District Court for the Middle District of Tennessee granted a request by the Department of Justice (DOJ) for a temporary restraining order (TRO) to close two pharmacies accused of...more

BCLP

The Long-Awaited Telemedicine Controlled Substance Prescribing Permit

BCLP on

Last week, the United States Congress passed a 250-page bill addressing the opioid crisis entitled SUPPORT for Patients and Communities Act (the “Opioid Act”). However, at page 56 of the Opioid Act, there is a short section...more

Baker Donelson

Expanded Telehealth Coverage in New Opioids Legislation

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On October 3, 2018, the Senate voted 98-1 to pass a compromise opioids response package that includes key provisions to expand telehealth coverage and reimbursement. The House had previously passed the opioids agreement...more

Foley & Lardner LLP

Florida’s New Law Changes Physician Responsibilities for Opioid Dispensing

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Florida’s House Bill (HB) 21, enacted to help combat opioid abuse, contains several noteworthy changes to Florida law that impact the dispensing of opioids. Effective July 1, 2018, dispensing providers must consult...more

K&L Gates LLP

K&L Gates Triage: The Opioid Epidemic: Federal and State Requirements on Medication-Assisted Treatment for Substance Abuse...

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In the sixth episode of our series on the national opioid crisis, Lauren Perry discusses some of the legal obligations for providers who prescribe controlled substances as treatment for substance abuse disorders....more

K&L Gates LLP

K&L Gates Triage: The Opioid Epidemic: DEA’s Role in Regulating Individuals and Entities Handling Controlled Substances

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In the fifth episode of our series on the national opioid crisis, Hilary Bowman discusses the Drug Enforcement Administration’s (DEA) role in regulating individuals and entities handling controlled substances, including...more

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